MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI

Model Number	87045
Medical Device Problem Codes	Power Conditioning Problem (1474); Impedance Problem (2950); Mechanics Altered (2984); Temperature Problem (3022); Data Problem (3196)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ablation effect was unable to be observed.During an ablation procedure for atrial fibrillation with a intellanav open-irrigated catheter, a significant drift issue was observed and a slight base noise appeared.Power/current was supplied to the left pulmonary vein (lpv) ridge at 35-40w with irrigation flow 30ml/min.There was almost no change in impedance or temperature, making it difficult to observe the ablation.The physician also wanted the catheter to bend more for better operability.The procedure was completed and there were no patient complications.
Event or Problem Description
It was reported that ablation effect was unable to be observed.During an ablation procedure for atrial fibrillation with a intellanav open-irrigated catheter, a significant drift issue was observed and a slight base noise appeared.Power/current was supplied to the left pulmonary vein (lpv) ridge at 35-40w with irrigation flow 30ml/min.There was almost no change in impedance or temperature, making it difficult to observe the ablation.The physician also wanted the catheter to bend more for better operability.The procedure was completed and there were no patient complications.It was further reported that the issue occurred about an hour into the procedure.There were no error codes displayed and no loss of temperature monitoring from the catheter.The device was in power mode.Impedance during ablation was 120 +/- 5 ohms (standby 170-180 ohms).There were no tracking issues, but electrodes 1 and 2 had signal noise.It was noted that this was the first case of the day.The patient did not have any implanted devices or stents.The c-arm was in use near the patient and the software had been upgraded on 17apr2019 to lumipoint version 3.0.
Additional Manufacturer Narrative
Device evaluated by manufacturer: visual inspection of the catheter showed there was dried body fluid on the handle, main body tubing and distal end.Dried saline was present on the distal end and inside several irrigation ports.Inspection of the steering knob and tension control knob revealed proper function on both lock and unlock positions and no abnormal resistance was felt when actuating the steering mechanism.Electrical continuity testing, while manipulating the catheter shaft, revealed no open or short circuits, as checked manually using a multi-meter and breakout box.All electrode, sensor and thermocouple resistances measured in specification and were typical.The catheter was soaked for thirty minutes, during which time it went through multiple ablations/agitation cycles.No temperature issues prior to, during or afterward were observed.Signal noise was present on the 1-2 bipole during ablation, however, the values fell within current device specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8822153
• Report Number: 2134265-2019-08665
• Device Sequence Number: 19634723
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023759674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAESTRO 4000 GENERATOR; MAESTRO 4000 GENERATOR; METRIQ PUMP; METRIQ PUMP; RHYTHMIA HDX MAPPING SYSTEM (LUMIPOINT SOFTWARE); RHYTHMIA HDX MAPPING SYSTEM (LUMIPOINT SOFTWARE); MAESTRO 4000 GENERATOR; METRIQ PUMP; RHYTHMIA HDX MAPPING SYSTEM (LUMIPOINT SOFTWARE)
• Patient Age: 72 YR